Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance (PIONEER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01030185
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : September 6, 2013
Information provided by (Responsible Party):
NovaShunt AG

Brief Summary:

To investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance.

Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.

Condition or disease Intervention/treatment Phase
Ascites Device: NovaShunt's Automated Fluid Shunt implantation Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Open Label, Non-randomized Study to Investigate the Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance
Study Start Date : February 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: NovaShunt's Automated Fluid Shunt
The Automated Fluid Shunt (AFS) Device
Device: NovaShunt's Automated Fluid Shunt implantation
The Automated Fluid Shunt (AFS) Device consists of an implantable sealed housing which contains an internally powered pump with supportive electronic components and circuits, an implantable Peritoneal Catheter, implantable Bladder Catheter and a non-implantable Charger used for wireless recharging an AFS battery and collecting data from the Device.
Other Name: NovaShunt

Primary Outcome Measures :
  1. The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Paracentesis requirements [ Time Frame: 6 month ]
  2. Hematology [ Time Frame: 6 month ]
  3. Incidence of hemodynamic instability [ Time Frame: 6 month ]
  4. Incidence and severity of peripheral edema [ Time Frame: 6 month ]
  5. Patient Quality of Life. [ Time Frame: 6 month ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients ≥ 18 years of age
  • Recurrence of ascites defined as clinical reappearance of ascites within 4 weeks of initial paracentesis.
  • Cirrhosis of any etiology
  • Failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects
  • Dietary sodium restriction <88mEq/d.
  • Serum creatinine levels of ≤ 2.0 mg/dL for at least 7 days before study entry.
  • Total bilirubin levels of less than 3 mg/dL.
  • Expected survival of greater than 6 months
  • Written informed consent
  • Ability to comply with study procedures and ability to operate the device.
  • Women of childbearing age should use adequate contraceptives

Exclusion Criteria:

  • Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
  • Presence of peritoneal carcinomatosis
  • Advanced hepatocellular carcinoma, demonstrated by:

    1. One tumor that is >5 cm diameter
    2. 3 or more nodules of >3 cm diameter
    3. Portal thrombosis
  • Other evidence of a malignant Etiology for Ascites
  • Evidence of extensive ascites loculation
  • Gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to the inclusion in the study.
  • Hepatic encephalopathy in the two weeks prior to implant
  • Presence of a TIPS or surgical portosystemic shunt
  • Presence of Budd-Chiari syndrome
  • Previous liver transplant
  • Obstructive uropathy
  • Coagulopathy that could not be corrected to a prothrombin time INR <1.8,
  • Thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3
  • Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator
  • Any condition requiring emergency treatment
  • Pregnancy
  • Patients being in another clinical study that did not reach primary endpoint yet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01030185

Department of hepatology, UZ Leuven, campus Gasthuisberg
Leuven, Belgium, 3000
Clinic of Internal Diseases, MHAT "Tokuda Hospital Sofia" JSC
Sofia, Bulgaria, 1404
Military Medical Academy, Clinica of Gastroenterology and Hepatology
Sofia, Bulgaria, 1606
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Charité, Campus Virchow Klinikum
Berlin, Germany, 13353
Medizinische Klinik und Poliklinik I
Bonn, Germany, 53105
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität
Frankfurt, Germany, 60590
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Hospital General Uneversitario de Alicante
Alicante, Spain, 03010
Hospital de la Santa Pau I Sant Creu
Barcelona, Spain, 08025
Sponsors and Collaborators
NovaShunt AG
Principal Investigator: Jose Such, MD Hospital General Uneversitario de Alicante C/ Maestro Alonso 109 - 03010 Alicante /Alacant, Spain

Responsible Party: NovaShunt AG Identifier: NCT01030185     History of Changes
Other Study ID Numbers: 2009-AAR-002
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: September 2013

Keywords provided by NovaShunt AG:
liver cirrhosis

Additional relevant MeSH terms:
Pathologic Processes
Natriuretic Agents
Physiological Effects of Drugs